Diana Gomez Padilla

Aim rhy
• me
of the Give
equipment
• The tableting machine is
used to produce tablets
(pharmaceutical, cosmetic,
etc.).
• They are capable of
producing a large number
of tablets per minute,
improving the capacity of a
company.
•
Parts of a tablet press
Platina: where it is located
the matrix that will give the
shape and
size to the tablet (the matrix
It is interchangeable).
decreasing the pressure.
Bottom punch: its face
superior form with
walls of the matrix
cavity that regulates size
and
weight.

Upper punch: penetrates

the matrix and exerts
pressure Feeding hopper:
place the substance or
on the dust, enough to
granules to be compressed,
form the tablet. Regulates
is
hardness increasing or
provided with a device that

Mechanical devices: give

movement that facilitates
slipping of dust on the
matrix.
(Barros,
2012).
facilitates the sliding of the dust in the matrix.
 The lower punch descends to the

OPERATI maximum and the upper punch rises

to the maximum, the hopper
advances until it is above the matrix
ON and fills it with the powder or
granules.
N Compression: the hopper is
withdrawn backwards, the lower
punch maintains its position and the
upper punch penetrates the matrix,
exerting the necessary pressure to
form a tablet.

The upper punch rises, the lower

punch rises until its upper edge is at
the level of the platen. The hopper
advances so that its free edge collides
with the tablet and removes it
(Barros, 2012).
 TABLET MACHINE OPERATION VIDEO

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► I «4)) 0:31 /1:39
 Process
es
Tablet presses can form tablets through different
processes, depending on the characteristics of the powder
or granules themselves:
• Direct compression: The powder is added to the hopper
after all ingredients have been mixed.
• Dry granulation: The powders are first subjected to
processes to form larger particles, and are subsequently
compressed in the tablet press.
• Wet granulation: Before compression the powder is
moistened to form granules.
üofidoclos

-RIIC I

Classificatio
n
motor machines
Simple single punch machines
Simple multiple and rotary punch machines.
Equipment validation
PURPOSE
Describe the tablet press validation
procedure to ensure it meets
installation, operating, and
performance qualification
requirements.

RESPONSIBILITY
It is the responsibility of the
production manager, the validation
manager — — - - — -
Installation qualification

•• Manual of
user
• Manual of
maintenance
• Replacement
Parts List
. meI__•__
 1. Installation qualification
1.3. Product feeding unit control
1.1 Calibration
• The following meters must be calibrated: • Determine the rotation speed of the
• Tablet revolution speed product feed unit with variable
• Back pressure at pre-compression station settings according to the
• Back pressure at main compression station
manufacturer's specifications.

Prepare for
1.4 Setting the tablet exit station
1.2 Adjustment of compression forces of
pre-compression and main compression each tablet diameter a trial set of
stations two top punches like standard
• Use a suitable pressure gauge to punches. Incorporate a single swipe
adjust compression forces. and run the tablet with a
Lue lacebo product or perform the
Requirements
All tablets compressed with manipulated punches must be discharged by
the machine at 100%.
 Verify alarm control.

Perform the calibration requirements, identified in the manual or established

by the validation team.

Operate the equipment at low, medium and high speed according to the
operations manual to verify operation control.
2. Verify that all switches and push buttons are working properly.
Qualification
Establish operation, maintenance and calibration
operational
procedures.

Establish a training program for relevant personnel.

Run a pilot batch for each product on the tablet press and
investigate the items listed below.
 2. Operational qualification
2.1 Granulation loading
Requirements
• Granulations do not stick in the feeding system.

2.2 Granulation segregation

Take samples of the granulation before tableting and during tableting (beginning, middle and end of the
pilot batch); Analyze the granulometric distribution of the samples taken.
Requirements
• No significant deviations should be found in the particle size distribution.
2.3 Controls in process
Load the sample quantity of tablets to be taken at routine intervals up to the number of punches available in
the tablet table.

2.4 Control of the tablet exit station

To evaluate the self-adjusting properties, collect all tablets discharged by the machine and evaluate their
weight.
 3. Performance
rating
%
Evaluation of tablet compressionGO
capabilities and features.

Procedure
The compression capabilities and
characteristics of the tablet (i.e. content
uniformity, thickness, hardness, friability,
weight variation and
 • Cosmos. (2021). Technical and Commercial
Information on Tablet Presses. Accessed May 27,
2021. Recovered from: Technical information on
Tablet Presses (cosmos .com.mx)
• Barros, K. g. (2012). Operation and performance
qualification (OQ and PQ) of the Stokes II tablet
press of the pharmaceutical technology laboratory
of the ESPOCH school of biochemistry and
pharmacy by compressing a placebo. Polytechnic
Higher School of Chimborazo, Ecuador.
Bibliography • SA (SF). Validation Standard Operating Procedures.
Section Val 700.00. Tablet Press, pp. 358-361